An interventional study of Radiostereometric Analysis and total hip arthroplasty with RSA bead implantation in Total Hip Arthroplasty and Acetabular Cup, sponsored by Midwest Orthopaedics at Rush. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by Midwest Orthopaedics at Rush · Not applicable, Interventional, and Other
The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.
The proposed study is a prospective evaluation of data from patients undergoing primary total hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for this study. All patients that qualify for the study per the inclusion-exclusion criteria and provide written informed consent will receive the Trident II acetabular cup and RSA beads. Implant stability, through RSA, will be measured throughout the first two postoperative (post-op) years per the following schedule: immediate post-op and 6 weeks, 3 months, 6 months, 1 year, and 2 years following surgery. Patients will be discharged and seen for follow-up assessments as per standard of care. Adverse events that are related to the index joint will be collected. Health outcome questionnaires will be collected. The health outcome questionnaires will include: EQ-5D, HOOS JR and Harris Hip Score. Health outcome questionnaires will be completed pre-operatively and again at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery. Conventional x-ray analysis will be performed pre-operatively and again at 6 weeks, 1 year and 2 years following surgery.
Exclusion Criteria:
Subjects receive the Trident II acetabular cup and RSA beads and undergo a series of post-operative RSA exams.
Radiation: Radiostereometric Analysis · Procedure: total hip arthroplasty with RSA bead implantation
RSA exams of the operative hip are received post-op day 1, and at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery
Patients receive RSA beads inserted into the bone surrounding the Trident II implant.
Does the Trident II Cup achieve acceptable fixation to the underlying bone?
The Trident II Cup proximal migration will be assessed. Migration of less than 0.2mm at 2 years and without continuous migration between post-operative year 1 and 2 will indicate acceptable fixation.
Time frame: 3 years
What are the migration patterns of the Trident II acetabular cup over the first two post-operative years?
Migration patterns will be assessed using RSA analysis.
Time frame: 3 years
Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?
The health status and functional outcome will be assessed via Harris Hip Score.
Time frame: 3 years
Is there a significant difference in health status and functional outcome before and after hip arthroplasty using Trident II Cup?
The health status and functional outcome will be assessed via EQ-5D.
Time frame: 3 years
Is there a correlation between radiolucent lines measured by Charnley-DeLee zone analysis and migration characteristics using RSA?
X-ray radiographs will be taken at pre-op, 6 weeks, 1 year and 2 year appointments. It may take up to 3 years after study start for all patients to reach the 2 year visit mark, depending on how long enrollment takes.
Time frame: 3 years
Can inducible displacements measured at 1 year post-operative distinguish patients identified by RSA measurements as having inadequate fixation?
Inducible displacements will be measured using RSA exams at the 1 year follow-up. It may take up to 2 years after study start for all patients to reach the 1 year visit mark, depending on how long enrollment takes.
Time frame: 2 years
Plan to share: No
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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